BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 854145 · Received October 11, 2006

    Report

    Report Number
    2954323-2006-01026
    Event Type
    Malfunction
    Date Received
    October 11, 2006
    Date of Event
    September 30, 2006
    Report Date
    October 11, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED IF PRODUCT IS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS RECEIVING ERRATIC READINGS IN BLOOD GLUCOSE TESTS. CUSTOMER RECEIVED READINGS OF 213 , 226, 215, 190, 34 MG/DL AND 241 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID, FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. * 0615006

    Patients

    Seq Age Sex Outcome Treatment
    1 YR